In connection with their appointment to the Board of Directors, on February 28, 2013, the Company granted to Mr. David Eckoff, Mr. Sumio “Sumi” Takeichi and Dr. John Norris each an option to purchase 1,500,000 shares of the Company’s common stock. The options vest 250,000 shares every six months, have an exercise price of $0.032, and expire on February 28, 2023. The fair value of each option granted is $0.023 and was estimated on the date of grant using the Black-Scholes pricing model with the following assumptions: dividend yield at 0%, risk-free interest rate of 1.97%, an expected life of 5 years, and volatility of 96%. The aggregate computed value of these options is $105,010, and this amount will be charged as an expense over the three year vesting period.
Item 2.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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Corporate Overview
Our Company is a pattern recognition company that uses advanced mathematical techniques to analyze large amounts of data to uncover patterns that might otherwise be undetectable. The Company operates primarily in the field of molecular diagnostics where such tools are critical to scientific discovery. The terms artificial
intelligence and machine learning are sometimes used to describe pattern recognition tools.
HDC’s mission is to use its patents, intellectual prowess, and clinical partnerships principally to identify patterns that can advance the science of medicine, as well as to advance the effective use of our technology in other diverse business disciplines, including the high-tech, financial, and healthcare technology markets.
Our historical foundation lies in the molecular diagnostics field where we have made a number of discoveries that play a critical role in developing more personalized approaches to the diagnosis and treatment of certain diseases. However, our SVM assets in particular have broad applicability in many other fields. Intelligently applied, HDC’s pattern recognition technology can be a portal between enormous amounts of otherwise undecipherable data and truly meaningful discovery.
Our Company’s principal asset is its intellectual property which includes advanced mathematical algorithms called Support Vector Machines (SVM) and Fractal Genomic Modeling (FGM), as well as biomarkers that we discovered by applying our SVM and FGM techniques to complex genetic and proteomic data. Biomarkers are biological indicators or genetic expression signatures of certain disease states. Our intellectual property is protected by more than 90 patents that have been issued or are currently pending around the world.
Our business model has evolved over time to respond to business trends that intersect with our technological expertise and our capacity to professionally manage these opportunities. We initially sought only to use our SVMs internally in order to discover and license our biomarker signatures to various diagnostic and pharmaceutical companies. Today, our commercialization efforts include: utilization of our discoveries and knowledge to help develop diagnostic and prognostic predictive tests; licensure of the SVM and FGM technologies directly to diagnostic companies; and, the formation of new ventures with domain experts in other fields where our pattern recognition technology holds commercial promise.
Operational Activities
The Company markets its technology and related developmental expertise to prospects in the healthcare, biotech, and life sciences industries. Given the scope of some of these prospects, the sales cycle can be quite long, but management believes that these marketing efforts may produce favorable results in the future.
NeoGenomics License
On January 6, 2012, we entered into a Master License Agreement (the “NeoGenomics License”) with NeoGenomics Laboratories, Inc. (“NeoGenomics Laboratories”), a wholly-owned subsidiary of NeoGenomics, Inc. (“NeoGenomics”). Pursuant to the terms of the NeoGenomics License, we granted to NeoGenomics Laboratories and its affiliates an exclusive worldwide license to certain of our patents and know-how to use, develop and sell products in the fields of laboratory testing, molecular diagnostics, clinical pathology, anatomic pathology and digital image analysis (excluding non-pathology-related radiologic and photographic image analysis) relating to the development, marketing production or sale of any “Laboratory Developed Tests” or LDTs or other products used for diagnosing, ruling out, predicting a response to treatment, and/or monitoring treatment of any or all hematopoietic and solid tumor cancers excluding cancers affecting the retina and breast cancer. We retain all rights to in-vitro diagnostic (IVD) test kit development.
Upon execution of the NeoGenomics License, NeoGenomics Laboratories paid us $1,000,000 in cash and NeoGenomics issued to us 1,360,000 shares of NeoGenomic’s common stock, par value $0.001 per share, which had a market value of $1,945,000 using the closing price of $1.43 per share for NeoGenomic’s common stock on the OTC Bulletin Board on January 6, 2012. In addition, the NeoGenomics License provides for milestone payments in cash or stock, based on sublicensing revenue and revenue generated from products and services developed as a result of the NeoGenomics License. Milestone payments would be in increments of $500,000 for every $2,000,000 in
GAAP revenue recognized by NeoGenomics Laboratories up to a total of $5,000,000 in potential milestone payments. After $20,000,000 in cumulative GAAP revenue has been recognized by NeoGenomics Laboratories, we will receive a royalty of (i) 6.5% (subject to adjustment under certain circumstances) on net revenue generated from all Licensed Uses except for the Cytogenetics Interpretation System and the Flow Cytometry Interpretation System and (ii) a royalty of 50% of net revenue (after the recoupment of certain development and commercialization costs) that NeoGenomics Laboratories derives from any sublicensing arrangements it may put in place for the Cytogenetics Interpretation System and the Flow Cytometry Interpretation System.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
NeoGenomics Laboratories agreed to use it best efforts to commercialize certain products within one year of the date of the license, subject to two one-year extensions per product if needed, including a “Plasma Prostate Cancer Test”, a “Pancreatic Cancer Test”, a “Colon Cancer Test”, a “Cytogenetics Interpretation System”, and a “Flow Cytometry Interpretation System.” In January 2013, NeoGenomics informed the Company of its intent to continue under the terms of the license and therefore extend the license for the first of its one-year extensions.
If NeoGenomics Laboratories has not generated $5.0 million of net revenue from products, services and sublicensing arrangements within five years, we may, at our option, revoke the exclusivity with respect to any one or more of the initial licensed products, subject to certain conditions.
The Company believes our relationship with NeoGenomics is instrumental in our medical and diagnostic testing development. We further believe the majority, if not all, of our applications in the medical field will be done in conjunction with the NeoGenomics License.
Plasma Test for Prostate Cancer
NeoGenomics has initiated the development of the Blood Test for Prostate Cancer under the direction of Dr. Maher Albitar using the genes patented by HDC.
Cytogenetic Analysis
Cytogenetic analysis is the science of studying chromosomes. Microscopic evaluation of individual chromosomes remains the first step in the evaluation of the human genome. Cytogenetic analysis is performed on almost all patients with hematopoietic diseases (blood cancers such as leukemia and lymphoma) and on a significant number of patients with solid tumors. The collected data is useful for diagnosis, prognosis and monitoring of diseases. Currently most of the analysis is performed manually by specially trained technicians. The work is labor-intensive and subjective. Computer automation of this work could significantly reduce cost and improve the quality of the test.
NeoGenomics is currently working on development, validation and commercialization of this new image analysis tool for cytogenetic analysis under the direction of Dr. Maher Albitar.
Flow Cytometry
Management believes that our efforts to develop an SVM-based diagnostic test to help interpret flow cell cytometry data for myelodysplastic syndrome (pre-leukemia) has resulted in a successful proof of concept. The Company, along with NeoGenomics, is now capable of completing development, final validation and commercialization of the new diagnostic test for the interpretation of flow cytometry data. This test has been licensed to NeoGenomics for final development.
SVM Capital, LLC
In January 2007, SVM Capital, LLC (“SVM Capital”) was formed as a joint venture between HDC and Atlantic Alpha Strategies, LLC (“Atlantic Alpha”) to explore and exploit the potential applicability of our SVM technology to quantitative investment management techniques. Atlantic Alpha’s management has over thirty years of experience in commodity and futures trading. Atlantic Alpha reports that the SVM technology is now working well in two distinct investment areas.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
First, it is being applied to price data. Utilizing open, high, close, low and volume SVM utilizes an 85 dimensional space to make future predictions. This price driven model is using fifty exchange traded funds (ETFs) which give it a global perspective. Much testing and refinement of this model has been accomplished and is being used for trading by Atlantic Alpha.
Second, Atlantic Alpha is applying SVM technology to quarterly fundamental corporate data such as sales, earning and projected earnings. SVM is utilized to separate stocks which should outperform and underperform in the next quarter based on current data. The Company is actively marketing the SVM Capital product to potential institutional users of the technology.
Retinalyze
On February 17, 2012, the Company announced the commercial launch of Retinalytics SVM
TM
, to assist Ophthalmologists and Optometrists in the Detection of Macular Degeneration. While the first Retinalytics SVM
TM
product released focuses on age-related macular degeneration, the Company continues to develop a second Retinalytics SVM
TM
product using fundoscopic images of retinal vessels to assist eye care professionals in the detection of Alzheimer’s disease.
The volume of images processed thus far been significantly less than expected and revenues to date from Retinalyze have been negligible. Retinalyze, LLC continues to evaluate options to improve the product with the goal of solving this slower than expected adoption issue, thereby allowing the analysis of a higher volume of scans. In addition, the Company is evaluating all options related to the product with the goal of optimal commercialization of this technology.
Intellectual Property Developments
Currently, the Company holds the exclusive rights to 57 issued U.S. and foreign patents covering uses of SVM and FGM technology for discovery of knowledge from large data sets. The Company also has 23 pending U.S. and foreign patent applications covering uses of the SVM technology as well as biomarkers and diagnostic methods that have been discovered using the SVM technology. The reduction in the total number of issued and pending patents during the past year resulted from the Company’s decision to allow certain foreign patents issued and/or filed in countries that were deemed to have lower strategic value to lapse. This in turn reduced the Company’s total expenses for patent maintenance.
Intel
In October 2012, the US Patent and Trademark Office (“USPTO”) issued a reexamination certificate for Intel’s U.S. Patent No. 7,685,077, which issued in 2010 with claims covering SVM-RFE. The reexamination certificate confirms the patentability of the claims as amended during the reexamination proceedings.
While disappointed with issuance of the reexamination certificate, the Company draws encouragement from the fact that the USPTO has agreed that all elements of the Company’s patented SVM-RFE method are present in the Intel claims. A fundamental principle of patent law is that the addition of one or more elements to a patented claim does not avoid infringement. In this case, Intel merely added a standard computer operation to the Company’s SVM-RFE method. Furthermore, possession of a patent on series of steps does not avoid infringement of a patent covering a subset of those steps.
The Company submitted a request to the USPTO to initiate interference proceedings once the reexamination certificate was issued and has subsequently received a final rejection in the application that was filed to provoke the interference. The reasoning behind the rejection has been uniformly criticized in decisions by both the Patent Office Board of Appeals and the Federal Appeals Court in cases with nearly identical facts. A response referring to these decisions has been submitted to the USPTO, and reversal of the rejection is expected, although the USPTO has yet to act on this response.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
Three Months Ended March 31, 2013 Compared with Three Months Ended March 31, 2012
Revenue
For the three months ended March 31, 2013, revenue was $284,139 compared with $285,629 for the three months ended March 31, 2012. The revenue earned during the first quarter of 2013 and 2012 is primarily related to the licensing revenue recognition for the NeoGenomics License.
Operating and Other Expenses
Amortization expense was $65,680 for both the three months ended March 31, 2013 and 2012. Amortization expense relates primarily to the costs associated with filing patent applications and acquiring rights to the patents.
Professional and consulting fees totaled $279,083 for the three months ended March 31, 2013, compared with $293,758 for the same 2012 period. The relatively flat decrease is due primarily to lower costs associated with professional service fees of accounting services and patent filing fees.
Legal fees remained relatively flat with fees totaling totaled $39,155 during the three months ended March 31, 2013 and $31,173 during the same period in 2012.
Research and development expense was $35,151 for the three months ended March 31, 2013, and $35,930 for the same period in 2012. This expense for research and development relates primarily to work completed under the NeoGenomics License.
Compensation expense of $166,025 for the three months ended March 31, 2013 was lower than the $290,818 reported for the comparable 2012 period. The decrease is attributed to a reduction in full time employees.
Other general and administrative expense decreased to $114,333 for the three months ended March 31, 2013, compared to $184,036, for the same period in 2012. This decrease was due to the elimination of expenses paid in connection with the NeoGenomics transaction, the elimination of investor relations charges, and by reduced travel expenses.
Loss from Operations
The loss from operations for the three months ended March 31, 2013 was $4
15,288,
compared to $
615,766
for the three months ended March 31, 2012. This reduction was due to lower costs primarily associated with compensation and other general and administrative expenses.
Other Income and Expense
The Company received a portion of the NeoGenomics license fee in NeoGenomics stock. The Company has chosen to measure the gain or loss on the value of this asset using the fair value option method. During the three month period ending March 31, 2013, the change in the NeoGenomics stock fair value increased by $730,100, which is recorded as other income in the statements of operations. During the same three month period in 2012, the change in the NeoGenomics stock fair value increased by $353,600.
There was no interest income for the three months ended March 31, 2013, compared to $781 in 2012. Interest income decreased because the Company had less cash on hand to invest throughout the 2013 period.
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
Net Income / Loss
The net income for the three months ended March 31, 2013 was $314,812, compared to a loss of $261,385 for the three months ended March 31, 2012. The net income was due primarily to the gain on the sale of NeoGenomics stock.
The earnings attributable to common shareholders was $280,607 for the three months ended March 31, 2013 compared to a loss of $646,232 in the three months ended March 31, 2012. This significant change is related to the accrual of the special dividend due to the Series B Holders as a result of the NeoGenomics transaction which occurred in the three month period ended March 31, 2012.
Earnings per share were $0.001 for the three month period ended March 31, 2013 compared to loss per share of $0.003 for the quarterly period ended March 31, 2012.
Liquidity and Capital Resources
Our ability to continue as a going concern is dependent upon our licensing arrangements with third parties, achieving profitable operations, obtaining additional financing and successfully bringing our technologies to the market. The outcome of these matters cannot be predicted at this time. Our financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classifications of the assets and liabilities that might be necessary should we be unable to continue in business.
If the going concern assumption was not appropriate for our financial statements then adjustments would be necessary in the carrying value of assets and liabilities, the reported expenses and the balance sheet classifications used. Such adjustments may be material.
At March 31, 2013, the Company had $85,195 in cash and cash equivalents and total current liabilities of $1,128,296. The primary amount of current liabilities relates to $1,024,988 in deferred revenue. Additionally, we continue to sell our NeoGenomics Stock in order to fund operations. Although the NeoGenomics Stock has increased in value, the number of shares and amount of cash we can generate from the sale of NeoGenomics Stock is subject to fluctuating market and price conditions. As a result we do not believe we have sufficient resources to meet all of our current obligations unless the Company is able to secure revenue via licensing activity or other forms of fund raising either in the debt or equity markets. None of these options are definitive and there can be no assurances the Company will be successful in these financing efforts.
The Company has taken steps to reduce the Company’s expenditures in order to reduce the “burn rate” to approximately $185,000 per month. These steps included reducing expenses and allocating our remaining cash reserves for our operational requirements at a reduced level.
The Company has relied primarily on equity and debt financing for liquidity. The Company must increase revenues in order to generate sufficient cash to continue operations. The Company’s plan to have sufficient cash to support operations is comprised of selling its NeoGenomics Stock, generating revenue through licensing its significant patent portfolio, providing services related to those patents, and obtaining additional equity or debt financing. The Company has been unable to generate significant revenue, as further described above. As a result, the Company has implemented a cash conservation program.
The following table summarizes our contr
actual obligations.
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Total
|
|
|
1 Year
Or Less
|
|
|
More Than
1 Year
|
|
Office Lease
|
|
$
|
14,800
|
|
|
$
|
14,800
|
|
|
$
|
-
|
|
Total
|
|
$
|
14,800
|
|
|
$
|
14,800
|
|
|
$
|
-
|
|
HEALTH DISCOVERY CORPORATION
Management’s Discussion and Analysis, continued
Off-Balance Sheet Arrangements
The Company has no off-balance sheet arrangements that provide financing, liquidity, market or credit risk support or involve leasing, hedging or research and development services for our business or other similar arrangements that may expose us to liability that is not expressly reflected in the financial statements.
Forward-Looking Statements
This Report contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 12E of the Securities Exchange Act of 1934, including or related to our future results, certain projections and business trends. Assumptions relating to forward-looking statements involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond our control. When used in this Report, the words “estimate,” “project,” “intend,” “believe,” “expect” and similar expressions are intended to identify forward-looking statements. Although we believe that assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate, and we may not realize the results contemplated by the forward-looking statement. Management decisions are subjective in many respects and susceptible to interpretations and periodic revisions based on actual experience and business developments, the impact of which may cause us to alter our business strategy or capital expenditure plans that may, in turn, affect our results of operations. In light of the significant uncertainties inherent in the forward-looking information included in this Report, you should not regard the inclusion of such information as our representation that we will achieve any strategy, objective or other plans. The forward-looking statements contained in this Report speak only as of the date of this Report as stated on the front cover, and we have no obligation to update publicly or revise any of these forward-looking statements. These and other statements which are not historical facts are based largely on management’s current expectations and assumptions and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those contemplated by such forward-looking statements. These risks and uncertainties include, among others, the failure to successfully develop a profitable business, delays in identifying customers, and the inability to retain a significant number of customers, as well as the risks and uncertainties described in “Risk Factors” section to our Annual Report for the fiscal year ended December 31, 2012.